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Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Collaborator:
Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
Information provided by (Responsible Party):
Deniz Inal-Ince, Hacettepe University
ClinicalTrials.gov Identifier:
NCT01658046
First received: July 31, 2012
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD)
 Other: Neuromuscular electrical stimulation
Other: Endurance training
Other: Quadriceps strength training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hacettepe University:

Primary Outcome Measures:
  • Incremental shuttle walk test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The incremental shuttle walk test was performed in an enclosed corridor. Patients were required to walk back and forth, turning around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients followed the rhythm dictated by the audio signal.


Secondary Outcome Measures:
  • Endurance shuttle walk test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    An endurance shuttle walk test was used to measure endurance walking capacity. The endurance shuttle walk test was performed 85% of peak oxygen consumption as predicted from the incremental shuttle walk test.


Enrollment: 27
Study Start Date: July 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NMES group
10 weeks neuromuscular electrical stimulation plus endurance training and quadriceps strength training.
 Other: Neuromuscular electrical stimulation
Bilateral quadriceps NMES using a four-channel portable electrical stimulator. Biphasic symmetric constant current impulses with a pulse width 300 µs, a frequency of 50 Hz, and duty cycle of 10 s on and 20 s off was applied for 20 min per day, 2 days per week for 10 weeks.
Other: Endurance training
Endurance training consists of 30 minutes of aerobic exercise (15 minutes on treadmill and 15 minutes on stationary bicycle) at 80% of maximal heart rate
Other: Quadriceps strength training
Quadriceps resistance training was applied using free weights for 2 days per week for 10 weeks according to 1 repetition maximum, starting at 45% for two sets.
Sham Comparator: Control group
10 weeks sham neuromuscular electrical stimulation plus endurance training and quadriceps strength training.
 Other: Endurance training
Endurance training consists of 30 minutes of aerobic exercise (15 minutes on treadmill and 15 minutes on stationary bicycle) at 80% of maximal heart rate
Other: Quadriceps strength training
Quadriceps resistance training was applied using free weights for 2 days per week for 10 weeks according to 1 repetition maximum, starting at 45% for two sets.

Detailed Description:

Skeletal muscle dysfunction is common and impaires exercise capacity in patients with chronic obstructive pulmonary disease (COPD)Exercise training is the main component of the treatment of COPD.

Neuromuscular electrical stimulation (NMES) is successful in COPD patients who are unable to perform exercise training. The NMES has positive effect on peripheral muscle function, exercise capacity and breathlessness in activities of daily living in COPD patients who had an abnormal body composition or who were too dyspneic to leave their home. A nonrandomized uncontrolled study has shown that application of NMES at home for improved exercise capacity in patients with better-preserved muscle mass. Evidence from a preliminary study without applying sham NMES revealed that NMES applied as complementary to ambulatory respiratory rehabilitation program increased quadriceps strength, quality of life and six minute walk distance in severe to very severe patients.

Despite documented benefits of NMES in COPD patients, the place of NMES as an adjunct to pulmonary rehabilitation in COPD patients who were able to do regular endurance and strength training on is unknown. Therefore, the purpose of this study was to compare the effects of NMES plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, dyspnea, fatigue, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of chronic obstructive pulmonary disease
  • being 35-75 years of age
  • being eligible to participate in endurance trainin
  • no acute exacerbation in last month, no change in drugs and no usage of antibiotics in last three weeks

Exclusion Criteria:

  • medical conditions which could place patient at risk during neuromuscular electrical stimulation and exercise training (orthophedic and neuromuscular disorders, metal implants in the lower limbs, advanced heart failure, aortic stenosis, deep venous thrombosis a cardiac pacemaker, >50 mmHg pulmonary artery pressure and/or an acute exacerbation of symtomps in the preceeding four weeks)
  • being unable to understand the questionnaires and unable to cooparate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658046

Locations
Turkey
Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
Ankara, Turkey, 06280
Sponsors and Collaborators
Hacettepe University
Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
Investigators
Principal Investigator: Deniz Inal-Ince, PhD, PT Hacettepe University
  More Information

No publications provided

Responsible Party: Deniz Inal-Ince, PhD, PT, Associated Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT01658046     History of Changes
Other Study ID Numbers: NMES-COPD, Hacettepe University
Study First Received: July 31, 2012
Last Updated: August 3, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Hacettepe University:
COPD
exercise
neuromuscular electrical stimulation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013